Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The potential effects of combining manual soft tissue release and physical exercise training on lung function, exercise capacity, and cardiac autonomic function in patients with moderate and severe chronic obstructive pulmonary disease were investigated.
Chronic obstructive pulmonary disease (COPD) commonly presents with accessory respiratory muscle tightness and weakness, affecting chest wall compliance and lung elasticity. However, traditional physical therapy interventions, including pursed-lip breathing, sputum clearance techniques, and respiratory muscle training, are often used in treatment guidelines, with few studies focusing on muscle release for the accessory respiratory muscles. Although the effects of manual therapy on lung function and chest tightness in COPD have been demonstrated, the effects of soft tissue release combined with exercise intervention on COPD, including lung function, exercise capacity, and cardiac autonomic function, remain unknown. Therefore, this study proposes a randomized controlled trial to investigate the effects of manual soft tissue release combined with exercise training on lung function, exercise capacity, and cardiac autonomic function in patients with COPD. It is expected that the results of this study will demonstrate that combining manual soft tissue release with exercise training may increase gas exchange in the lungs, reduce respiratory effort, improve co-morbidities, delay disease progression, and enhance patient quality of life and clinical intervention.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | The intervention group will receive combining manual soft tissue release and exercise training. |
|
| Control group | Active Comparator | The control group will receive combining myofascial release and exercise training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual soft tissue release | Behavioral | The manual soft tissue release includes muscle energy techniques and passive stretching, targeting the anterior scalene, upper trapezius, pectoralis major, pectoralis minor, and diaphragm. Three times a week for six weeks, with three rounds per session, each session having three repetitions, with a 30-second break in between, lasting 15 to 30 seconds each time. |
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume in 1 s (FEV1) | FEV1 is measured by the lung function test, and the unit presented will be in percent and liter. | Change from baseline (0 week) to follow-up (12 weeks) |
| forced vital capacity (FVC) | FVC is measured by the lung function test, and the unit presented will be in percent and liter. | Change from baseline (0 week) to follow-up (12 weeks) |
| FEV1/FVC ratio | FEV1/FVC ratio is measured by the lung function test, and the unit presented will be in percent. | Change from baseline (0 week) to follow-up (12 weeks) |
| expiratory reserve volume (ERV) | ERV is measured by the lung function test, and the unit presented will be in liter. | Change from baseline (0 week) to follow-up (12 weeks) |
| functional residual capacity (FRC) | FRC is measured by the lung functions test, and the unit presented will be in liters. | Change from baseline (0 week) to follow-up (12 weeks) |
| inspiratory capacity (IC) | IC is measured by the lung functions test, and the unit presented will be in liters. | Change from baseline (0 week) to follow-up (12 weeks) |
| inspiratory reserve volume (IRV), | IRV is measured by the lung functions test, and the unit presented will be in liters. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of perceived exertion (RPE) | RPE is measured by the cardiopulmonary exercise test. This scale ranges from 0 (very light activity) to 10 (maximum effort activity). | Change from baseline (0 week) to follow-up (12 weeks) |
| Oxygen consumption (VO2) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kun-Ling Tsai, Ph.D. | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University | Tainan | 701 | Taiwan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study population will be randomized and separated in two groups, experimental and control group.
Not provided
Not provided
Not provided
Not provided
|
| Myofascial release | Behavioral | The myofascial release includes suboccipital muscle, anterior chest wall myofascial, and anterior neck myofascial. Three times a week for six weeks, with three rounds per session, each session having three repetitions, with a 30-second break in between, lasting 15 to 30 seconds each time. |
|
| Exercise training | Behavioral | The exercise training includes aerobic exercise training by treadmill. The initial intensity is set at 60% to 85% of the average speed measured during the patient's six-minute walk test (6MWT). Intensity adjustments will be made using the Modified Borg Scale (scores ranging from 4 to 7). Training duration is 30 minutes, three times a week for six weeks. |
|
| Change from baseline (0 week) to follow-up (12 weeks) |
| residual volume (RV) | RV is measured by the lung function test, and the unit presented will be in liters. | Change from baseline (0 week) to follow-up (12 weeks) |
| total lung capacity (TLC) | TLC is measured by the lung function test, and the unit presented will be in liters. | Change from baseline (0 week) to follow-up (12 weeks) |
| tidal volume (TV) | TV is measured by the lung function test, and the unit presented will be in liters. | Change from baseline (0 week) to follow-up (12 weeks) |
| vital capacity (VC) | VC is measured by the lung function test, and the unit presented will be in liters. | Change from baseline (0 week) to follow-up (12 weeks) |
VO2 is measured by the cardiopulmonary exercise test, and the unit presented will be in milliliters of oxygen consumed per minute (ml/min).
| Change from baseline (0 week) to follow-up (12 weeks) |
| oxygen saturation | oxygen saturation is measured by the oximeter, and the unit presented will be in percent | Change from baseline (0 week) to follow-up (12 weeks) |
| heart rate (HR) | HR is measured by cardiopulmonary exercise test, and the unit presented will be in beat per minute (BPM) | Change from baseline (0 week) to follow-up (12 weeks) |
| blood pressure (BP) | BP is measured by the cardiopulmonary exercise test, which is divided into two parameters: systolic blood pressure (SBP) and diastolic blood pressure (DBP). The unit presented will be in millimeters of mercury (mmHg). | Change from baseline (0 week) to follow-up (12 weeks) |
| Diaphragmatic mobility | Diaphragmatic mobility is measured by the ultrasound, and the unit presented will be in millimeters | Change from baseline (0 week) to follow-up (12 weeks) |
| Cardiac Autonomic Function | Cardiac Autonomic Function is measured by heart rate variability of electrocardiography, and the unit presented will be in millisecond (ms) and millisecond square (ms2) | Change from baseline (0 week) to follow-up (12 weeks) |
| six minute walk test (6-MWT) | 6-MWT assesses the distance a person can walk within 6 minutes, and the unit presented will be in meters. | Change from baseline (0 week) to follow-up (12 weeks) |
| maximal expiratory pressure (MEP) | MEP is measured by the pressure meter, and the unit presented will be in centimetre of water (cmH2O). | Change from baseline (0 week) to follow-up (12 weeks) |
| maximal inspiratory pressure (MIP) | MIP is measured by the pressure meter, and the unit presented will be in centimetre of water (cmH2O). | Change from baseline (0 week) to follow-up (12 weeks) |
| St. George's Respiratory Questionnaire (SGRQ) | SGRQ is assessing how obstructive airway disease affects overall health, daily life, and well-being. Scores range from 0 to 100, with higher scores indicating more limitations. | Change from baseline (0 week) to follow-up (12 weeks) |
| fatigue severity scale (FSS) | FSS is assessing the impact of fatigue on a person's activity and lifestyle. There are nine items, and each item is scored from 1 to 9 (strongly disagree to strongly agree). Higher total scores indicate more severe fatigue. | Change from baseline (0 week) to follow-up (12 weeks) |
| Modified Medical Research Council (mMRC) | mMRC is assessing the subjective degree of breathlessness by patients during physical activity. It rates on a scale from 0 to 4, with a higher rate indicating the worst possible shortness of breath. | Change from baseline (0 week) to follow-up (12 weeks) |
| 36-Item Short Form Health Survey (SF-36) | SF-36 is assessing the subjective survey health status and quality of life. It consists of eight sections, with scores ranging from 0 to 100. Higher scores indicate better health and less disability. | Change from baseline (0 week) to follow-up (12 weeks) |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000089803 | Myofascial Release Therapy |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D008405 | Massage |
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided